Method, device, and system for delivery of therapeutic agents to the eye

ABSTRACT

A method, device, and system for easier, consistent, and comfortable delivery of therapeutic agents to the front of the eye.

PRIORITY INFORMATION

This application is a continuation Application of U.S. application Ser.No. 12/226,963, filed Feb. 18, 2009, the entire contents of which ishereby incorporated herein by reference. U.S. application Ser. No.12/226,963 is a National Stage application of International ApplicationNo. PCT/US2007/010981, filed May 4, 2007, which claims the benefit ofU.S. Provisional Application No. 60/797,533, filed May 4, 2006, theentire contents of which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

There are many ocular disorders that require treatment by theapplication of therapeutic agents to the front of the eye. For example,glaucoma is the second most common cause of blindness in the UnitedStates. About two million Americans have glaucoma, and only about halfof those patients with glaucoma are aware of it because the disease isgenerally asymptomatic. Because of the asymptomatic nature of thedisease, patients often have trouble complying with glaucoma therapy.Adding to patient compliance issues is the need to apply eye drops tothe front of the eye, which will decrease the ocular pressure in theeyes of glaucoma patients. Many patients simply have trouble applyingdrops to their eyes.

Other ocular disorders requiring the application of therapeutic agentsto the front of the eye include keratitis sicca, corneal ulcers(bacterial and viral), conjunctivitis, and allergies. Each of thesedisorders, as well as others, require the application of artificialtears, ointments, antibiotics, and/or antiviral agents to the front ofthe eye to be treated adequately. In addition, patients who arepost-ocular surgery often need to prevent post-surgical infection orinflammation by applying anti-inflammatory agents and antibiotics to thefront of the eye. Like many glaucoma patients, patients affected by theforegoing disorders often have difficulty complying with treatmentbecause of difficulty applying therapeutic agents or eye drops to thefront of the eye.

What is needed is a method, system, and device whereby patients withocular disorders may comply with treatment requiring the application oftherapeutic agents to the front of the eye. What is needed is a method,system, and device whereby patients with ocular disorders can routinelyand consistently have medications applied to their eyes without anydifficulty, fear, or discomfort of placing eye drops or othermedications in their eyes.

BRIEF SUMMARY OF THE INVENTION

Accordingly, it is an object of this invention is to provide a method,device, and system for easier, comfortable, and more consistent deliveryof opthalmic therapeutic agents to the front of the eye by allowing aphysician to place a drug delivery device in the patient's eye.

The present invention relates to a device containing therapeutic agents.The device may be inserted by a physician or eye care professional,rather than by a patient, which will allow the therapeutic agents to beapplied to the eye without patient anxiety about inserting eye drops inthe eye. Upon insertion, the device will be placed around the entirecircumference of the cornea rather than simply being placed in the lowerfornix of the eye. After insertion, the device will be comfortable. Inthe preferred embodiment of the invention, the inner diameter of thedevice would be 13-19 mm and the width of the device measured on theexternal edges will measure 1-5 mm.

The device may be inserted into a patient's eye on either a long-term(3-6 months) or a short-term basis. After the therapeutic agents in thedevice are depleted and effective agents are no longer being liberatedby the device, a patient may return to his/her physician for insertionof a new device or for replenishment of the device with additionaltherapeutic agents. The device may be totally biodegradable, and ifshort-term treatment is necessary, a biodegradable device may not bereplaced. If long-term treatment is necessary, a biodegradable devicemay either be replaced or replenished with additional therapeuticagent(s). If the therapeutic agent is a solution or crystalline drug, adrug delivery limiting membrane such as polyvinyl alcohol may be placedon the device. The device may be used in conjunction with contact lensesand other ocular appliances.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, to one of ordinary skill in the art, is set forthmore particularly in the remainder of the specification includingreference to the accompanying drawing in which:

FIG. 1 depicts the top view of the device having an elliptical outeredge and an inner edge that is circular in shape.

FIG. 2 depicts the side view of the device having an elliptical outeredge and an inner edge that is circular in shape.

FIG. 3 depicts the top view of the device having a toric shape.

DETAILED DESCRIPTION OF THE INVENTION

One embodiment of the invention is a device having an outer edge that iselliptical in shape 1 and an inner edge that is circular in shape 2. Inanother embodiment of the invention, the device is toric in shape. Inyet another embodiment of the invention, the device is C-shaped.

The device may have a barrier membrane along all or part of the device.One or more therapeutic agents are incorporated into the barriermembrane allowing therapeutic agents to be applied to the front of theeye. The amount of therapeutic agents delivered to the front of the eyemay be varied by varying the dimensions of the barrier membrane. Thedimensions of the device may range from 13-19 mm in the inner diameterand 1-5 mm in width measured on the outer edges of the device. Thedevice may be composed of a soft or rigid polymer. In yet anotherembodiment of the invention, the outer edge of the device may becomposed partially or entirely of metal to provide structural supportfor the device.

In another embodiment of the invention, the device may be used by beingplaced along the outer edge of a contact lens or made a part of acontact lens. In this embodiment of the invention, the inner diameterand width of the device will vary depending upon the contact lens withwhich the device is used.

If a therapeutic agent is incorporated in a barrier membrane along allor part of the device is soluble or crystalline, the device may includea delivery limiting membrane such as polyvinyl alcohol.

In another embodiment of the invention, the device is convex in shape.In a preferred embodiment of the invention, the apex of the convexity 3of the device touches the inner circular edge of the device.

In another embodiment of the invention, the device is combined with oneor more therapeutic agents. The therapeutic agents may be precipitatedwithin the polymer of which the device may be composed. The therapeuticagents will dissolve or hydrolyze such that they will be delivered intothe fluid bathing the front of the eye.

In yet another embodiment of this invention, the device is composed of abiodegradable polymer that contains one or more therapeutic agents. Thetherapeutic agents may be loaded into the biodegradable polymer insolution, precipitated in the biodegradable polymer, or chemically boundto the biodegradable polymer. The therapeutic agents will be releasedinto the patient's eye when the biodegradable polymer hydrolyzes ordissolves.

The invention claimed is:
 1. A device for delivery of therapeutic agentsto the eye, comprising a polymeric structure containing one or moretherapeutic agents that conforms to the curvature of a patient's outereye and extends around the circumference of a patient's cornea.
 2. Adevice for delivery of therapeutic agents to the eye comprising: a. apolymeric structure that conforms to the curvature of a patient's outereye and extends around the circumference of a patient's cornea; and b. abarrier membrane containing one or more therapeutic agents.
 3. Thedevice of claim 2, wherein the barrier membrane runs along the entirebottom surface of the polymeric structure.
 4. The device of claim 2,wherein the barrier membrane runs along a portion of the bottom surfaceof the polymeric structure.
 5. The device of claim 1, wherein thepolymeric structure contains one or more therapeutic agents that areprecipitated in the polymer and that will dissolve to allow delivery ofthe agents into the eye.
 6. The device of claim 2, wherein the polymericstructure contains one or more therapeutic agents that are precipitatedin the polymer and that will dissolve to allow delivery of the agentsinto the eye.
 7. A system of delivering therapeutic agents to the frontof the eye comprising the device of claim
 1. 8. A system of deliveringtherapeutic agents to the front of the eye comprising the device ofclaim
 2. 9. A system of delivering therapeutic agents to the front ofthe eye comprising the device of claim
 3. 10. A system of deliveringtherapeutic agents to the front of the eye comprising the device ofclaim
 4. 11. A system of delivering therapeutic agents to the front ofthe eye comprising the device of claim
 5. 12. A system of deliveringtherapeutic agents to the front of the eye comprising the device ofclaim 6.